The Safety and Effectiveness of Ganciclovir in the Prevention of Cytomegalovirus (CMV) of the Eyes and Disease of the Stomach and Intestines in Patients With HIV
- Conditions
- Gastrointestinal DiseasesCytomegalovirus RetinitisHIV Infections
- Registration Number
- NCT00001034
- Brief Summary
To evaluate the safety and efficacy of oral ganciclovir for prophylaxis against cytomegalovirus (CMV) retinal and gastrointestinal mucosal disease in HIV-infected patients with severe immunosuppression.
The most recent treatments against CMV disease have been ganciclovir and foscarnet. Until recently, both drugs required intravenous administration. An oral form of ganciclovir, if shown to be effective therapy against CMV, would be a more suitable method of administration for prophylaxis.
- Detailed Description
The most recent treatments against CMV disease have been ganciclovir and foscarnet. Until recently, both drugs required intravenous administration. An oral form of ganciclovir, if shown to be effective therapy against CMV, would be a more suitable method of administration for prophylaxis.
Patients are randomized in a 2:1 ratio to receive either oral ganciclovir or placebo for a minimum of 12 months. PER AMENDMENT 9/19/94: Patients who have not reached a study endpoint may choose to continue blinded prophylaxis or discontinue blinded prophylaxis and begin open-label ganciclovir. PER AMENDMENT 5/2/95: After the common closing date (6/3/95) patients who have not met a CMV end point or experienced a serious toxicity that required permanent discontinuation of active oral ganciclovir will be eligible to receive open-label oral ganciclovir through an open-label extension phase of study 023 until 8/31/95.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 850
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (17)
Community Consortium of San Francisco
🇺🇸San Francisco, California, United States
Denver CPCRA / Denver Public Hlth
🇺🇸Denver, Colorado, United States
Wilmington Hosp / Med Ctr of Delaware
🇺🇸Wilmington, Delaware, United States
Veterans Administration Med Ctr / Regional AIDS Program
🇺🇸Washington, District of Columbia, United States
AIDS Research Consortium of Atlanta
🇺🇸Atlanta, Georgia, United States
AIDS Research Alliance - Chicago
🇺🇸Chicago, Illinois, United States
Louisiana Comm AIDS Rsch Prog / Tulane Univ Med
🇺🇸New Orleans, Louisiana, United States
Comprehensive AIDS Alliance of Detroit
🇺🇸Detroit, Michigan, United States
Henry Ford Hosp
🇺🇸Detroit, Michigan, United States
Schering - Plough Corp
🇺🇸Kenilworth, New Jersey, United States
Scroll for more (7 remaining)Community Consortium of San Francisco🇺🇸San Francisco, California, United States